WO2007062070A1 - Implant d’articulation à facette et procédure - Google Patents

Implant d’articulation à facette et procédure Download PDF

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Publication number
WO2007062070A1
WO2007062070A1 PCT/US2006/045114 US2006045114W WO2007062070A1 WO 2007062070 A1 WO2007062070 A1 WO 2007062070A1 US 2006045114 W US2006045114 W US 2006045114W WO 2007062070 A1 WO2007062070 A1 WO 2007062070A1
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WO
WIPO (PCT)
Prior art keywords
elastic material
facet joint
synthetic elastic
implant
synthetic
Prior art date
Application number
PCT/US2006/045114
Other languages
English (en)
Inventor
David M. Hooper
Original Assignee
Abbott Spine, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Spine, Inc. filed Critical Abbott Spine, Inc.
Publication of WO2007062070A1 publication Critical patent/WO2007062070A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4405Joints for the spine, e.g. vertebrae, spinal discs for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/562Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30075Properties of materials and coating materials swellable, e.g. when wetted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30242Three-dimensional shapes spherical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30291Three-dimensional shapes spirally-coiled, i.e. having a 2D spiral cross-section
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0071Three-dimensional shapes spherical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0091Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Definitions

  • This invention relates to a facet joint implant and a method for distracting a facet joint and maintaining separation of the facet joint.
  • synovial joints The facet joints, knees, and elbows are sometimes referred to as synovial joints.
  • a synovial joint allows movement between two bones.
  • the ends of the bones are covered with a material called articular cartilage. This material is a slick spongy material that allows the bones to glide against one another without much friction.
  • a watertight sack made of soft tissue and ligaments.
  • This sack creates what is called the "joint capsule".
  • the ligaments are soft tissue structures that hold the two sides of the facet joint together.
  • the ligaments around the facet joint combine with the synovium to form the joint capsule that is filled with fluid (synovial fluid). This fluid lubricates the joint to decrease the friction.
  • the facet joint can often become painful during the degenerative process in the spine. Loss of disc height can reduce the separation of opposing facet joints and alters the biomechanics of those joints.
  • the cartilage of the joint may become compromised or destroyed resulting in bone on bone contact in the joint. This may cause significant pain.
  • This invention provides a solution to one or more of the deficiencies and disadvantages described above.
  • this invention is a method for repairing a facet joint of a human vertebra having a joint capsule surrounding the facet joint, comprising: introducing a synthetic elastic material into the facet joint.
  • the synthetic elastic material can be introduced through the joint capsule into the facet joint or, alternatively, introduced through the bone into the facet joint to thereby maintain separation of the facet joint.
  • the synthetic elastic material can be a hydrogel.
  • the synthetic elastic material can be introduced as a fully polymerized implant or, alternatively, as a polymerizable composition that polymerizes to form the hydrogel within the facet joint.
  • the synthetic elastic material in one embodiment, can be in a dehydrated or partially dehydrated form prior to introduction into the facet joint, and which swells upon hydration in the facet joint.
  • the method includes distracting the facet joint prior to introduction of the synthetic elastic material.
  • the synthetic elastic material is formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
  • this invention is a method for repairing a facet joint of a human vertebra having a joint capsule surrounding the facet joint, comprising: introducing a solid swellable synthetic elastic material into the facet joint.
  • the synthetic elastic material is introduced through the joint capsule into the facet joint.
  • the synthetic elastic material is introduced through bone into the facet joint.
  • the method includes distracting the facet joint prior to introduction of the synthetic elastic material.
  • the elastic material swells after being introduced into the facet joint.
  • the synthetic elastic material is introduced in the form of a folded or rolled solid swellable polymerized implant.
  • the synthetic elastic material is an elastomer that is formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
  • this invention is a method for repairing a facet joint of a human vertebra having a joint capsule surrounding the facet joint, comprising: introducing a polymerizable composition into the facet joint, wherein the polymerizable composition forms a synthetic elastic material in the facet joint.
  • the polymerizable composition is introduced through the joint capsule into the facet joint.
  • the polymerizable composition is introduced through bone into the facet joint.
  • the method includes distracting the facet joint prior to introduction of the polymerizable composition.
  • the synthetic elastic material is initially formed as a swellable polymerized composition which swells in the facet joint.
  • the synthetic elastic material is an elastomer that is formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
  • this invention is an implant comprising a solid synthetic elastic material and adapted for use as a facet joint implant.
  • the implant is thus of a size and dimensions during use that allow it to be used as a facet joint implant.
  • the synthetic elastic material can be in the form of a swellable polymerized composition.
  • the synthetic elastic material can be formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
  • the synthetic elastic material is in the form of a hydrogel.
  • this invention is a method for manufacturing a facet implant, comprising forming a synthetic elastic material into an implant adapted for use as a facet implant in a human spine.
  • the synthetic elastic material employed in the practice of this invention provides a surface to enhance lubrication within the facet joint, which can reduce pain associated with degenerated facet joints.
  • the elastic material is relatively inexpensive.
  • the method introduces the elastic material into the facet joint in a relatively non-invasive procedure.
  • the elastic material is advantageously benign, biocompatible, elastic, and pliable, and can be formed from synthetic polymers previously used in the human body. Thus, at least some of the polymers that can be used in the practice of this invention are advantageously commercially available.
  • the elastic material can be introduced as an at least partially dehydrated solid in a shape that conforms to the cavity within the facet joint.
  • the at least partially dehydrated solid becomes re-hydrated after being introduced into the facet joint.
  • the elastic material can thus swell to a larger size than the incision or hole that the elastic material is introduced through, thereby preventing the swelled elastic material from undesirably becoming expelled from the facet joint.
  • the elastic material can be readily removed if, for example, it is later desired to remove the facet joint if a spinal fusion procedure is performed.
  • FIG. 1 illustrates a cross-sectional view of a facet joint, with the polymerizable composition being injected into the facet joint through the joint capsule.
  • FIGS. 2A, 2B, and 2C illustrate representative views of a synthetic elastic material being introduced into a facet joint through an incision in the joint capsule.
  • FIG. 3 illustrates a representative view of a synthetic elastic material being introduced into a facet joint through a hole in the bone.
  • FIGS. 4A-4K illustrate representative shapes of solid synthetic elastic material that can be introduced into a facet joint according to this invention.
  • FIG. 5 illustrates a synthetic elastic material within a facet joint depicted in as introduced and swelled forms.
  • FIG. 1 illustrates a cross-section of a facet joint 10.
  • the facet joint 10 includes the joint capsule 12 that attaches to the bone 14, 15 of an upper and lower vertebra.
  • the joint capsule 12 and bones 14, 15 together define an inner cavity 16 that normally holds synovial fluid.
  • the joint capsule 12 surrounds the inner cavity on the perimeter, and the bones 14, 15 define the upper and lower ends of the inner cavity 16.
  • the synovial fluid provides lubrication for the facet joint. If the facet joint degenerates, there can be a lessoning of synovial fluid, reduction in space between the bones 14, 15 such that painful bone-on-bone contact occurs.
  • the present invention provides a synthetic elastic material of appropriate shape and size to be placed in the cavity 16 so that bone-on-bone contact is reduced or eliminated, thereby reducing or eliminating pain for a patient.
  • the implant may also provide lubrication for the facet joint.
  • the distraction of the facet joint can be accomplished through techniques well known to one of skill in the art. In general, the distraction can be accomplished, for example, by wedging the facet joint apart, such as by using a ramped needle, screws, a wedge, an osteotome, or some specific delivery device.
  • the synthetic elastomeric material refers to man-made materials such polymers, as opposed to naturally occurring materials such as collagen, naturally occurring proteins, cartilage and so on.
  • the synthetic elastomeric material is a hydrogel.
  • hydrogels attract water.
  • the hydrogels used in the practice of this invention contain at least 25 percent by weight of water when fully hydrated and which contain this quantity of water in the facet joint.
  • the hydrogels contain at least 50 percent by weight of water and in certain embodiments contain at least 90 percent by weight of water.
  • the hydrogels in general are inert, solid, elastic, pliable and biocompatible.
  • the synthetic elastomeric material such as a hydrogel
  • introduced into the facet joint provides relief from the facet joints rubbing each other, and may provide lubrication between the joints.
  • the synthetic elastomeric material including a hydrogel, can be fully hydrated when introduced into the facet joint, or can be, for example, introduced as a swellable material (e.g., a dehydrated sheet) that attracts water and swells/rehydrates once introduced into the joint.
  • the synthetic elastic material can be in the form of a polymerizable composition to be introduced into the facet joint or a fully polymerized composition.
  • the final polymers can be cross-linked or not cross-linked. It should be appreciated that the polymerizable composition and the fully polymerized elastic material can be made from the same monomers and/or polymer precursors.
  • a polymerizable composition can be introduced into the cavity, which fully polymerizes within the cavity.
  • the polymerizable material can be partially polymerized prior to introduction into the cavity.
  • a polymerization catalyst or initiator may be needed.
  • the polymerizable composition polymerizes in the facet joint to form an expandable elastic material, which swells up until its equilibrium water content is reached, i.e., a dehydrated elastic material is introduced into the cavity and swells as it rehydrates.
  • the elastic material may be a hydrogel.
  • the elastic material formed from the polymerizable composition in the joint need not necessarily be swellable to be useful in the practice of this invention.
  • the polymerizable composition can be introduced into the facet joint 10 such as by injection using a suitable syringe fitted with a hypodermic needle 20 or cannula.
  • a suitable syringe fitted with a hypodermic needle 20 or cannula.
  • the hole in the joint capsule caused by the needle or in the bone may heal naturally or may be sutured, patched, or filled with a suitable material to seal the hole.
  • the bone can be filled with bone material, adhesive, or other filler, then capped or plugged.
  • a metal screw or a screw formed of a material that forms bone over time can be used to close the drilled conduit.
  • the polymerizable composition can be injected into a balloon that has been previously placed in the facet joint. The balloon, or some other containment system, serves to contain the polymerizable composition as it is injected.
  • a fully polymerized synthetic elastic material can be introduced into the facet joint.
  • the polymer is an expandable synthetic elastic material (e.g., a hydrogel), which swells until its equilibrium water content is reached.
  • a dehydrated synthetic elastic material is introduced into the cavity and swells as it rehydrates.
  • the synthetic elastic material used is a fully polymerized polymer to be introduced into the facet joint, it can be in the form of particles, or be in other forms such as in the form of a sheet or elongate rods (e.g., that resemble toothpicks). The sheet or elongate rods can be inserted through a minimally invasive hole either through the joint capsule or through the bone.
  • the implant whether a sheet or otherwise, is of a size and shape adapted to be inserted into the cavity of the facet joint.
  • the sheet is inserted in a dehydrated, reduced size such as in a folded, coiled, wrapped, or rolled shape, which upon hydration opens into a sheet within the facet joint.
  • an incision 22 can be made in the joint capsule 12 such as depicted in FIG. 2.
  • the incision such as in the shape of a round hole, is of sufficient size to permit the insertion of the implant 24 into the cavity 16 within the facet joint 10.
  • FIG. 5 illustrates a synthetic elastic material within a facet joint depicted in as introduced form 24a (in dotted lines) and swelled form 24b. It should be appreciated that the sizes depicted in the figures may not be to scale.
  • a slice 22A is made in the joint capsule 12 to provide an entrance incision for the synthetic elastic material, as depicted in FlG. 2B.
  • a rectangular hole can be made in the bone with an implant in the form of, for example, a sheet slid into the facet joint.
  • the implant 24 is in the shape of an elongate rod (e.g., "toothpick shaped") as depicted in FIG. 2C that is inserted through holes 22B cut at multiple points around the capsule 12.
  • the elongate implant 24 in FIG. 2C may swell within the joint to a larger size.
  • one or more rods can be inserted in the facet joint through one or more incisions.
  • a hole 30 can be drilled through bone 15 to permit the insertion of the implant 32 in the cavity 16. In either case the incision or hole can be optionally sealed after the implant has been introduced into the facet joint.
  • a dehydrated implant is introduced into the facet joint, and then the implant is hydrated to facilitate swelling, if sized appropriately the implant will not exit through the incision or hole in the bone, whether or not the incision or hole is subsequently sealed by the physician.
  • small synthetic elastic materials in the form of particles are used, under some circumstances it may be possible to introduce these particles into the facet joint such as by injection using a suitable syringe fitted with a hypodermic needle.
  • the hole in the joint capsule caused by the needle or in the bone may heal naturally or may be sutured, patched, or filled with a suitable material.
  • the bone can be filled with bone material, adhesive, or other filler, then capped or plugged.
  • a metal screw or a screw formed of a material that forms bone over time can be used to close the drilled conduit.
  • FIGS. 4A- 4M Representative shapes of solid synthetic elastic materials are shown in FIGS. 4A- 4M.
  • a representative elastic material in the shape of a sphere in hydrated form is depicted in FIG. 4A, with the sphere in a dehydrated, folded form depicted in FIG. 4B.
  • a cylindrical shape is depicted in FIG. 4C in its hydrated form, and in its dehydrated, folded form in FIG. 4D.
  • FIG. 4E shows a hydrated helix with FIG. 4F showing the helix in dehydrated form.
  • An implant of a hydrated, ovoid shape is depicted in FIG. 4G, with a folded, dehydrated ovoid depicted in FIG. 4H.
  • FIG. 4I depicts a folded, dehydrated oblong sheet with FIG.
  • FIG. 4J depicting a dehydrated oblong sheet that is not folded.
  • FIG. 4K depicts a rehydrated oblong sheet, formed by hydration of the shape in either FIG. 4I or FIG. 4J.
  • FIG. 4L depicts an elongate rod, which can be inserted into the joint. In one embodiment the elongate rod hydrates to expand within the joint.
  • FIG. 4M shows a sheet in the form of a roll, which unfurls within the joint to form a sheet.
  • the height, width, and depth separately in each occurrence of the shapes can vary widely depending on the size of the joint for a given person at the given part of the spine.
  • the area to be treated is believed to be approximately 120 square millimeters.
  • the shapes can also include rectangles, ovals, and circles.
  • the thickness of the implants can vary, such as being less than 2 millimeters when dehydrated, and about 2 to about 3 millimeters in the absence of a compressive load.
  • the rods are typically about 3 to about 15 millimeters in length and a diameter of less than 1 millimeter.
  • the rods can be inserted through a needle and then rehydrated in the joint.
  • the rods can have tapered or blunt ends.
  • a single implant is introduced into the facet joint.
  • two or more implants are inserted into the facet joint, such as for example in the case of multiple, small spheres, rods, or other particles being inserted or injected into the cavity.
  • the shapes depicted in FIGS. 4A-4K are intended to be representative. Other shapes and sizes can be used.
  • the polymers that can be used in the practice of this invention to make the polymerizable compositions and polymerized elastic materials include but are not limited to polyacrylonitrile, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, polymethacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, (pliable) epoxy polymers, and combinations thereof, as well as the monomers used to make such polymers.
  • the polymers and copolymers of this invention can be made of monomers such as but not limited to that can be employed to make the polymers used in this invention include but are not limited to hydroxyalkyl acrylates such as 2-hydroxy ethyl methacrylate, acrylic acid, acrylonitrile, urea, ethylene oxide and propylene oxide, acrylamide, tetrafluoroethylene, dimethylsiloxane, monomers used to form polyurethane such as polyols and diisocyanates such as diphenylmethane diisocyanate (MDI), monomers used to form pliable epoxy resins, vinyl alcohol, methacrylates including alkyl methacrylates such as methyl methacrylate, N-vinyl monomers such as N-vinyl-2- pyrrolidone, ethylenically unsaturated acids such as methacrylic acid, ethylenically unsaturated bases such as 2-(diethylamino) ethyl methacryl
  • polymer precursor (which can also be referred to as a "prepolymer”) refers to materials that are formed by the partial polymerization of monomers, such as to form chains by reaction of, for example, two to four monomer groups.
  • polymerization initiators or catalysts are required to cause polymerization.
  • Such compounds can be, for example, free radical initiators.
  • heat or light e.g., UV light
  • UV light can serve to initiate polymerization.
  • the synthetic elastic materials can contain a variety of other additives, such as pharmaceutically active compounds, analgesics, antibiotics, nutrients, building blocks for tissue generation, and so on.
  • a lubricating composition may be introduced concurrent with the synthetic elastic materials, such as additional synovial fluid, hyaluronic acid, and so on.
  • the implants can include radiographic markers such as strips of tantalum wire.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L’invention a pour objet une méthode pour réparer une articulation vertébrale humaine à facette ayant une capsule articulaire qui entoure l'articulation à facette. La méthode décrit un matériel élastique synthétique qui est introduit dans l'articulation à facette. Le matériel élastique synthétique peut être un polymère solide, enflable qui se développe par hydratation lorsque placé dans l'articulation à facette. L'invention inclut l'implant et la méthode pour fabriquer l'implant.
PCT/US2006/045114 2005-11-22 2006-11-21 Implant d’articulation à facette et procédure WO2007062070A1 (fr)

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US11/287,077 US20070118218A1 (en) 2005-11-22 2005-11-22 Facet joint implant and procedure
US11/287,077 2005-11-22

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WO2007062070A1 true WO2007062070A1 (fr) 2007-05-31

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